MalfunctionMMK
UNK
Received Nov 19, 2015
Report MW5058076 · MDR key 5249587
Device
Product problems
- Leak/Splash
- Chemical Spillage
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SINCE (B)(6) 2014, THERE HAS BEEN AN INCREASE IN EXPOSURE TO FORMALIN DUE TO CONTAINER SPILLS AND LEAKAGE FROM THE PREFILLED SPECIMEN CONTAINERS. LEAKING CONTAINERS OCCUR BOTH ON THE INITIAL HANDLING OF CONTAINERS BY THE MATERIALS MANAGEMENT STAFF AS WELL AS WHEN RESEALING AFTER THE SPECIMEN HAS BEEN ADDED. THE MATERIALS MANAGEMENT TEAM HAS COMMUNICATED WITH THE VENDOR AND RETURNED TWO SPECIMEN CONTAINERS TO THE VENDOR FOR EVAL.